Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT05370859
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who enroll in cessation services', 'timeFrame': '12 weeks after study start', 'description': 'Assessed using administrative records'}], 'secondaryOutcomes': [{'measure': 'Level of and change in motivation and self-efficacy to quit smoking', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Assessed using self-report on the weekly and 12-week survey'}, {'measure': 'Level of and change in anxiety and depression', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Assessed using self-report (PHQ-4) on the weekly and 12-week survey'}, {'measure': 'Number of smoking quit attempts', 'timeFrame': '12 weeks after study start', 'description': 'Assessed using self-report on the weekly and 12-week survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Behaviors', 'Cancer', 'Motivation']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being seen at the study recruitment sites for cancer treatment, who have a current cancer diagnosis and who are currently smoking. Other concurrent tobacco use is also acceptable.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An adult (18+)\n* Current smoker defined by: Has smoked 100 cigarettes in their lifetime (may be multi-tobacco users as long as they also use combustible cigarettes).\n* Any type of cancer (except non-melanoma skin cancer)\n* Anticipates receiving any of the following cancer treatments in the 3 months following enrollment: chemotherapy, surgery, immunotherapy, bone marrow or stem cell transplant, hormone therapy, or radiation\n* Access to the Internet\n\nExclusion Criteria:\n\n* Not smoked 100 cigarettes in their lifetime\n* \\< 18 years in age\n* Diagnosed with non-melanoma skin cancer\n* Not diagnosed with cancer\n* Does not anticipate receiving cancer treatments in the 3 months following enrollment\n* Has been previously enrolled in an existing Cancer Center Tobacco Treatment Program (TTP)\n* Not comfortable reading and responding to questions in English\n* No consistent access to the Internet'}, 'identificationModule': {'nctId': 'NCT05370859', 'acronym': 'mMe', 'briefTitle': 'mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study', 'orgStudyIdInfo': {'id': '18184'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mme Study Participants', 'description': 'Participants will complete a baseline survey, 11 weekly surveys, and a follow-up survey at 12 weeks', 'interventionNames': ['Other: There is no intervention for this study']}], 'interventions': [{'name': 'There is no intervention for this study', 'type': 'OTHER', 'description': 'There is no intervention or exposure for this study', 'armGroupLabels': ['Mme Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Cancer Center and affiliated sites', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor of Public Health Sciences', 'investigatorFullName': 'Kara Wiseman, MPH, PhD', 'investigatorAffiliation': 'University of Virginia'}}}}